Impacted Canine and Mixed-reality Technology - RCT
Alignment of an Impacted Canine Using Mixed-reality HoloLens 2 Goggles - a Randomized Clinical Trial
1 other identifier
interventional
72
1 country
1
Brief Summary
The goal of this clinical trial is to determine whether the use of HoloLens 2 mixed reality goggles for planning alignment of palatally impacted canine reduces: 1) treatment time and 2) the risk of complications compared to planning alignment of palatally impacted canine without HoloLens 2 goggles. Participants will have an impacted canine on palatal side. Researchers will use or will not use HoloLens 2 goggles in planning therapy Participants will wear fixed orthodontic appliances for the treatment of impacted canine. During treatment, attachment will fixed to an impacted canine and the direction of traction will be established.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
August 28, 2024
August 1, 2024
5 years
August 13, 2024
August 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Alignment duration
total duration of the phase of the alignment of impacted canine (in days)
6 months, 12 months
Secondary Outcomes (1)
Resorption
6 months, 12 months
Study Arms (2)
HOLO+
EXPERIMENTALHOLO-
ACTIVE COMPARATORInterventions
Planning of attachment position and traction direction with HoloLens 2 goggles
No planning of attachment position and traction direction with HoloLens 2 goggles
Eligibility Criteria
You may qualify if:
- Healthy boys/men and girls/women aged between 10 and 20 years.
- Palatally impacted canine on one side
- Axis of the canine \> 10 degrees to the midline as measured on a pantomographic radiograph
- During orthodontic treatment, in preparation for alignment of the impacted canine with adequate space for the retained canine
You may not qualify if:
- Dental abnormalities (hyperodontia, hypodontia, etc.)
- Impacted canines bilaterally
- Previous trauma to the teeth or face
- Congenital craniofacial malformations
- Systemic diseases that would hinder orthodontic treatment/operation
- Recent radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Piotr Fudalejlead
Study Sites (1)
Jagiellonian University Medical College
Krakow, 31-008, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 28, 2024
Study Start
October 1, 2021
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
August 28, 2024
Record last verified: 2024-08